NCT00880737已完成不适用
Prognostic Value of Computed Tomography (CT) Scan in Hemodynamically Stable Patients With Acute Symptomatic Pulmonary Embolism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 850
- 试验地点
- 1
- 主要终点
- The primary outcome considered will be death by any cause in the month following diagnosis.
研究概览
简要总结
The objectives of the PROTECT study are:
- To assess the role of CT pulmonary angiography in the risk stratification of hemodynamically stable patients with acute symptomatic pulmonary embolism (PE).
- To assess the role of transthoracic echocardiography in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
- To assess the role of 2 biomarkers (troponin and brain natriuretic peptide) in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
- To assess the role of the Pulmonary Embolism Severity Index (PESI) in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
- To assess the combined role of CT pulmonary angiography, transthoracic echocardiography, PESI, troponin I and brain natriuretic peptide in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute symptomatic Pulmonary Embolism (PE) confirmed by:
- •CT pulmonary angiography positive for PE
- •Ventilation/ perfusion lung scan with high likelihood of PE (according to PIOPED criteria)
- •V/Q ventilation/ perfusion lung scan inconclusive for PE or negative CT pulmonary angiography in a patient with thoracic symptoms and a lower limb ultrasound showing a positive diagnosis for deep vein thrombosis.
排除标准
- •Contraindication for CT pulmonary angiography (allergy to iodine contrasts or creatinin clearance < 30 ml/min).
- •Informed consent not obtained.
- •Pregnancy.
- •Life expectancy of less than 3 months.
- •Hemodynamic unstability defined as SBP < 90 mm Hg, need for cardiopulmonary reanimation, need for vasoactive drugs or orotracheal intubation.
- •Thrombectomy, insertion of filter in the cava vein, or need for fibrinolytic treatment for PE episode.
- •Participation in another clinical trial for treatment of PE.
结局指标
主要结局
The primary outcome considered will be death by any cause in the month following diagnosis.
时间窗: 30 days after PE diagnosis
次要结局
未报告次要终点
研究者
研究点 (1)
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